Vibrator appliance particularly useful for dialysis

ABSTRACT

A vibrator apparatus is provided. The vibrator apparatus includes a body weight support to support the body weight of a subject. The body weight support is attached to at least one arm, which includes a first arm portion and a second arm portion. The second arm is adjustably positionable with respect to the first arm portion. The vibrator apparatus also includes a vibrator assembly mounted on the second arm portion of the arm. The second arm portion is positionable relative to the first arm portion to engage an abdominal region of the subject and apply localized inwardly-directed mechanical vibrations.

FIELD AND BACKGROUND OF THE INVENTION

[0001] The present invention relates to a vibrator appliance, andparticularly to one useful for a peritoneal dialysis (PD) treatment. Theinvention also relates to a dialysis method and particularly to oneutilizing the novel vibrator appliance.

[0002] Peritoneal dialysis (PD) is a medical treatment administered whenthere is insufficient functioning of the kidneys. It is performed byinserting a sterile plastic catheter into the abdominal cavity of thesubject and instilling a dialysate solution to irrigate the peritoneumsuch that solutes transfer across the peritoneal membrane into thedialysate solution from the blood in the mesentery capillary network.This treatment does not require a machine, such as in hemodialysis, butdoes require much longer periods of time in order to achieve soluteremoval comparable to that of intermittent hemodialysis. Such atreatment is commonly performed in an ambulatory manner as a CAPD(Continuous Ambulatory Peritoneal Dialysis) treatment.

[0003] CAPD is usually performed in four 6-hour sessions during each24-hour period. In each session, the dialysate solution is instilledinto the abdominal cavity of the subject and permitted to dwell thereinfor a period of six hours, following which the dialysate solution isdrained, and a fresh dialysate solution is instilled. This relativelylarge number of sessions greatly disturbs the daily routine of thesubject. It also increases the risk of infection.

[0004] Various studies have been conducted on the application ofmechanical vibrations for improving the efficiency of waste removal byPD (peritoneal dialysis); see J.Rudov et al. Nephron 46:364-366 (1987);Levitt et al. Kidney International, Vol. 35, pp. 1145-1150 (1989); andUtsunomia-T et al., Nippon-Jinzo-Gakkai-Shi; January 1995; 37(1):24-8.The Rudoy et al. publication (1987) describes an improvement inperitoneal transfer on human subjects when subjected to mechanicalvibrations at a frequency of 24 Hz by a vibrator held by the patientperpendicular to the patient's abdomen; the Levitt et al. publication(1989) describes studies of the effects produced on the rate ofperitoneal transfer in rats by shaking the rats; and the Japanesepublication (1995) describes studies on the rate of peritoneal transferin rats by vibrating the abdominal wall at the rate of 80 Hz.

OBJECTS AND BRIEF SUBJECT OF THE INVENTION

[0005] Objects of the present invention are to provide a vibratorappliance particularly useful in peritoneal dialysis, and also animproved method of peritoneal dialysis. The apparatus and method of thepresent invention are particularly useful for CAPD, but may also be usedfor other PD treatments, such as APD (Automated Peritoneal Dialysis),and CCPD (Continuous Cycling Peritoneal Dialysis) usually administeredat home during the nighttime.

[0006] According to one aspect of the present invention, there isprovided an appliance to enhance the rate of removal of solutes during aperitoneal dialysis treatment of a subject, comprising: a holder to beapplied to the subject; and at least one vibrator device carried by theholder at a location thereof to engage the subject's abdomen and toapply localized, inwardly-directed mechanical vibrations thereto at afrequency of 1-15 Hz.

[0007] As will be described more particularly below, surprisingly goodresults were produced when the vibrator device applies the mechanicalvibrations at a frequency of 2-6 Hz,

[0008] In the preferred embodiments of the invention described below,there are two vibrator devices carried by the holder at locations toengage the opposite sides of the subject's abdomen and oriented to applyinwardly-directed mechanical vibrations towards the central region ofthe subject's abdominal cavity.

[0009] According to another aspect of the invention, there is provided amethod of administering a peritoneal dialysis treatment to a subjectcomprising a vibration session including: instilling a dialysatesolution into the peritoneal cavity of the subject; applying externallocalized mechanical vibrations to the front side of the abdomen of thesubject at a frequency of 1-15 Hz and an amplitude of 1-20 mm; anddraining the dialysate solution from the subject's abdominal cavity. Asindicated above, and as will be more fully described below, surprisinglygood results were obtained when the mechanical vibrations were applied,at a frequency of 2-6 Hz and at a amplitude of 5-10 mm, especially whentwo vibrator heads were used engaging the front side of the subject'sabdomen on opposite sides of its center line and oriented to directmechanical vibrations to the central region of the subject's abdominalcavity.

[0010] Thus, it was found that applying the vibrations at a frequency ofover 15 Hz did not permit the vibrations to propagate deeply into thebody cavity, and therefore the 24 Hz frequency mentioned in the J.Rudoyet al. publication cited above only produced a limited improvement inthe peritoneal dialysis treatment. It was also found that applying thevibrations at a frequency of less than 1 Hz also produced very limitedbenefits. Surprisingly good results were found in the frequency range of2-6 Hz, which produced an improvement of up to 150% in the soluteremoval rate, as compared to an improvement of about 30-40% whenapplying the mechanical vibrations at a frequency of 24 Hz as describedin the J.Rudoy et al. publication.

[0011] The optimum rate, preferably within the 2-6 Hz range, can bedetermined emperically for each subject, according to the size, buildand weight of the subject.

[0012] The vibrational amplitudes are preferably in the range of 1-20mm, best results having been obtained with amplitudes of 5-10 mm. Theseamplitudes are inversely related to the frequency; that is, at the lowerend of the above frequency range the vibrational amplitudes would be atthe higher end of the amplitude range, and vice versa. Preferably, thecombination of amplitude and frequency should be just below the levelproducing significant pain or discomfort to the subject, e.g., at thesecond limit of ISO Standard 2631.

[0013] Further features and advantages of the invention will be apparentfrom the description below.

BRIEF DESCRIPTION OF THE DRAWINGS

[0014] The invention is herein described, by way of example only, withreference to the accompanying drawings, wherein:

[0015]FIG. 1 illustrates one type of vibrator appliance constructed inaccordance with the present invention utilizing an electrically-actuatedvibrator;

[0016]FIG. 2 illustrates a rotary-motor type vibrator that may be usedin the appliance of FIG. 1;

[0017]FIG. 3 illustrates a solenoid-type of vibrator that may be used inthe appliance of FIG. 1;

[0018]FIG. 4 illustrates a piston-type vibrator appliance constructed inaccordance with the present invention;

[0019]FIG. 5 illustrates an air-bag type vibratory appliance constructedin accordance with the present invention;

[0020]FIG. 6 illustrates a moving-belt type vibrator applianceconstructed in accordance with the present invention;

[0021]FIG. 7 illustrates another vibratory appliance including a beltsupporting two electric motors rotating eccentric weights;

[0022]FIG. 8 illustrates a further appliance in which the vibrations areeffected by a pair of motors which cyclically tension and relax a beltapplied to the wearer's abdomen;

[0023]FIG. 9 is a plan view illustrating a further type of applianceconstructed in accordance with the present invention;

[0024]FIG. 10 is a rear view of the appliance of FIG. 9;

[0025]FIG. 11 is a plan view illustrating a still further applianceconstructed in accordance with the present invention;

[0026]FIG. 12 is a rear view of the appliance of FIG. 11;

[0027]FIG. 13 is a plan view of a still further appliance constructed inaccordance with the present invention;

[0028]FIG. 14 is a front view of the appliance of FIG. 13;

[0029]FIG. 15 is an artist's view of one form of vibrator applianceconstructed in accordance with the present invention; and

[0030]FIG. 16 illustrates a dialysis set particularly useful with theappliance and method of the present invention.

DESCRIPTION OF PREFERRED EMBODIMENTS

[0031] The vibrator appliance illustrated in FIG. 1 includes a holder 2of a closed loop configuration to enclose the wearer's abdomen,indicated by broken lines AB. Holder 2 carries two vibrators 3 a, 3 b,each slidably mounted on the holder by a slide 4 a, 4 b, to enable eachvibrator to be located so as to apply mechanical vibrations to oppositesides of the abdomen of the subject.

[0032] Holder 2 includes a back frame 2 a, and a front frame 2 bmounting the two vibrators 3 a, 3 b. One end of front frame 2 b ispivotal, by hinge 5, to the respective end of the back frame 2 a foropening and closing the holder. The opposite end of front frame 2 b islockable to the respective end of the back frame 2 a by a lock,schematically shown at 6, for locking the holder in its closedcondition. Both the back frame 2 a and the front frame 2 b includewidth-adjusting means, as shown at 7 and 8, respectively, for adjustingthe size of the holder to fit persons of different sizes. Such widthadjustment means 7, 8 may be of any conventional construction, such asslidable or telescoping sections in the respective frames.

[0033] Holder 2 may be worn by the subject in a self-supporting mannerwith the two vibrators 3 a, 3 b engaging the front side of the subject'sabdomen, on opposite sides of its center line. Thus, when the twovibrators 3 a, 3 b are energized, they produce mechanical vibrationswhich are inwardly-directed towards the center region of the subject'sabdominal cavity.

[0034] In the embodiment illustrated in FIG. 1, the two vibrators 3 a, 3b, are electrically-driven. FIG. 2 illustrates one example of such avibrator, in the form of a rotary motor 10 rotating a disc 11eccentrically mounting an arm 12 enclosed within a bellows 13 having ahead 14 engageable with the user's abdomen such that energization ofmotor 10 reciprocates the eccentric arm 12 and its head 14 to applymechanical vibrations to the wearer's abdomen. FIG. 3 ilustrates anotherexample of vibrator, in the form of a solenoid 15 reciprocating anarmature 16 enclosed within a bellows 17 and having a head 18 engagingthe wearer's abdomen to apply mechanical vibrations thereto upon theenergization of the solenoid. A still further example, including anelectric motor driving eccentric weights is described below withreference to FIG. 7. The displacements of the vibrations may be adjustedor changed by changing the eccentricity of arm 12 in the appliance ofFIG. 2, the current through the solenoid 15 in the appliance of FIG. 3,and the weights in the appliance of FIG. 7.

[0035] The use of the vibrator appliance illustrated in FIGS. 1-3 hasbeen found to enable a CAPD treatment to be divided into two 12-hoursessions, rather than four 6-hour sessions as in the conventional CAPDtreatment. Following is one example of such a two-session treatment:

[0036] In each session, dialysate solution is instilled into theabdominal cavity of the subject, and the two vibrators 3 a, 3 b aredriven to cause them to apply mechanical vibrations to the abdomen, at afrequency of 1-15 Hz, at a vibrational amplitude of 1-20 mm, and for aperiod of 15-60 minutes. After this dwell period, the dialysate solutionis drained from the suject; fresh dialysate solution is instilled andpermitted to dwell in the subject for the remaining 12-hour period ofthat session; and the dialysate solution is then drained. This completesone 12-hour session, whereupon the next 12-hour session is started, andthe foregoing sequence of steps is repeated. As indicated earlier, whenthe frequency was 2-6 Hz, the vibrational amplitude was 5-10 mm, and thedwell period was from about 30-40 minutes, surpringly improved resultswere obtained producing an improvement of up to about 150%, as comparedto a 30-40% improvement mentioned in the above-cited J.Rudoy et al.publication using 24 Hz vibrations.

[0037] These improved results enabled the normal four session CAPDtreatment to be reduced to two sessions, each session involving e.g., a40-minute dwell period accompanied by the vibrations, and immediatelyfollowed by, e.g., an 11-hour 20-minute dwell period not accompanied byvibrations. Thus, the 40-minute dwell period accompanied by vibrationswas found to remove substantially the same amount of solutes as a normal6-hour session in the conventional CAPD treatment. Such a 2-sessionregimen is not only much more convenient and substantially lessdisruptive of the daily routine of the patient than the usual 4-sessionregimen, but also substantially reduces the possibility of infection.

[0038] The two vibrators may be operated at the same constant frequency,at different frequencies, or with changing frequencies. They may beoperated in the same phase or in different phases. One or both vibratorsmay also be operated in a continuously changing phase angle. Bestresults were obtained when both vibrators were operated within the rangeof 2-4.5 Hz, with one vibrator operating at a slightly differentfrequency than the other (such as 2.5 Hz and 2.6 Hz, respectively) toproduce alternating in-phase and out-of-phase movements of the subject'sabdomen. The subject may be in a sitting, lying or standing positionduring the first part of each session when the vibrations are applied,but best results were obtained when the subject was in a sitting orsupine position.

[0039]FIG. 4 illustrates a vibrator appliance, similar to that of FIG. 1except that the vibrators, therein designated 23 a, 23 b, respectively,are in the form of fluid pistons movable within cylinders to apply thevibrations to the wearer's abdomen. In FIG. 4, each of the vibrators 23a, 23 b is shown as including a bellows 24 a, 24 b, enclosing the pistonof the respective vibrator. The pistons in vibrators 23 a, 23 b, may beoperated pneumatically or hydraulically. FIG. 4 schematicallyillustrates a pump or compressor 25 for operating these pistons. In allother respects, the vibrator appliance illustrated in FIG. 4 isconstructed and operates in substantially the same manner as describedabove with respect to FIG. 1, and therefore the corresponding elementsof the appliance are identified by the same reference numerals tofaciliate understanding.

[0040]FIG. 5 illustrates another form of vibrator appliance wherein theholder is in the form of a belt 32 to enclose the subject, and thevibrators are in the form of inflatable air bags 33 a, 33 b carried bythe belt on the opposite sides of the wearer's abdomen. The air bags 33a, 33 b are inflatable and deflatable at the desired frequency by acompressor 35.

[0041] Belt 32 includes a stiff back 36 and a front adjustment 37 foradjusting the belt to fit persons of different sizes. While FIG. 5illustrates a compressor 35 for both vibrators, it will be appreciatedeach vibrator could be provided with its own compressor particularly ifthey are to be operated at different frequencies or phases. The sameapllies with respect ot the appliance of FIG. 4.

[0042]FIG. 6 illustrates a further vibrator appliance, in which theholder includes a frame 40 to engage the back of the wearer, a firstbelt 41 to be applied around the wearer, and a second belt 42 to beapplied around the first belt 41. This appliance also includes twovibrators applying mechanical vibrations to the opposite sides of thewearer's abdomen. In this case, each vibrator includes a plurality ofplates 43 pivotally mounted at one end to the inner belt 41, and at theopposite end to the outer belt 42. The arrangement is such that whenbelt 42 is reciprocated, in the direction of arrows 44, the two groupsof plates 43 are pivotted through a plurality of positions from 0° to180°, and during such pivotal movements of these plates, they applymechanical vibrations to the wearer's abdomen. Thus, when the plates are0° to the two belts 41, 42, the vibrational amplitude is zero, but asthe plates move to positions of 90° to the two belts, they applymechanical vibrations to the wearer's abdomen at amplitudescorresponding to the widths of the plates.

[0043] Each vibrator thus includes one group of plates 43 pivotallymounted between the two belts 41, 42. The width of each plate 43decreases from the rear side to the front side of the respectivevibrator so that the vibrational amplitudes are correspondinglydecreased from the rear side towards the front side of the vibrator.

[0044]FIG. 6 schematically illustrates the front belt 42 as beingreciprocated by a pair of motors 45, 46, at the opposite ends of therear frame 40. An adjustment 47 for the rear frame 40, and an adjustment48 for the two belts 41, 42, enable the appliance to fit persons ofdifferent sizes.

[0045]FIG. 7 illustrates another appliance, including a belt 50 having aback adjustment 51 and a front adjustment 52 to enable the appliance tobe fitted to different size individuals. Belt 50 carries a pair ofvibrators 53 a, 53 b on its opposite sides to engage the opposite sidesof the wearer's abdomen. Each vibrator 53 a, 53 b includes an electricmotor 54 a, 54 b, driving a pair of eccentric weights 55 a, 55 b which,upon energization of the respective motors, apply mechanical vibrationsto the wearer's abdomen.

[0046]FIG. 8 illustrates an even more simplified construction, includinga back frame 60 having an adjustment 61, and front belts 62, 63 having afront adjustment 64. The back frame 60 carries a pair of electric motors65, 66 engaging the opposite ends of belts 62, 63 such that energizationof the electric motors cyclically tensions and relaxes the belts tocause them to apply mechanical vibrations to the opposite sides of thewearer's abdomen engaged by the belts.

[0047]FIGS. 9 and 10 illustrate another appliance 70 also including aholder in the form of a loop to be worn by the subject in aself-supporting manner. In this case, the appliance includes two basemembers 71, 72 coupled together by a hinge 73 and mounted to a stiff orrigid back plate 74 adapted to engage the back of the subject. The basemembers 71, 72 mount electrical motors 75, 76 which are eccentricallycoupled to one end of a pair of flexible belts 77, 78 adapted to engagethe front side of the subject's abdomen. The opposite ends of belts 77,78 are coupled together by a locking device or buckle 79.

[0048] A pair of vibrator heads 80, 81 are carried by the two belts 77,78. Heads 80, 81 extend inwardly of the loop to contact the front sideof the subject's abdomen on opposite sides of its center line and areoriented towards the central region of the subject's abdominal cavity.Thus, when the two electrical motors 75, 76 are energized, theireccentric connections to the flexible belt 77, 78 cyclically tension andrelax the belts causing the vibrator heads 80, 81 to apply mechanicalvibrations directed to the central region of the subject's abdominalcavity.

[0049] The front buckle or lock 79 is adjustable to permit the diameterof the loop to be adjusted according to the size of the subject. The twovibrator heads 80, 81 are slidable on the belts 77, 78 to permit them tobe optimally positioned in order to direct the mechanical vibrations tothe central region of the subject's abdominal cavity. The two hingedbase members 71, 72 may also be adjustable on the back plate 74. Thus,as shown in FIG. 10, the back plate 74 carries two parallel screws 82,83 rotate together by another screw 84. Screws 82, 83 on the back plate74 are received within nuts 85, 86 on the two base members 71, 72, suchthat rotation of the two screws 82, 83 by the common screw 84 moves thetwo base members 71, 72 up or down according to the direction ofrotation of screws 84.

[0050]FIGS. 11 and 12 illustrate a similar appliance as in FIGS. 9 and10, and therefore the same reference numerals have been used for thesame parts. In the appliance of FIGS. 11 and 12, however, the ends ofthe two base members 71, 72 are not hinged together, but rather areformed with parallel slots 91, 92 receiving threaded pins 93, 94. Inaddition, each base member 71, 72 has secured thereto a transverse rigidstrip 95, 96 adapted to be received within grooves 97, 98 formed in theback plate 74. Strips 95, 96 carried by the base members 71, 71, andgrooves 97, 98 in the back plate 74, are formed with a plurality ofopenings extending along the length of the strips and grooves,respectively, adapted to selectively receive threaded pins 99. Thus, bythreading pins 99 in selected openings in the strips 95, 96, and grooves97, 98, the position of the base members 71, 72 may be adjusted alongthe length of the back plate; and by tightening the threaded pins 93, 94in their respective slots 91, 92, the diameter of the appliance may beadjusted to fit different sized persons.

[0051]FIGS. 13 and 14 illustrate another appliance 100 which includes aloop enabling the appliance to be worn by the user in a self-supportingmanner, but further includes a pair of shoulder harnesses 102, 103 toaid the loop in supporting the appliance on the subject.

[0052] The appliance 100 illustrated in FIGS. 13 and 14 includes a basemember 104 at the front of the appliance, i.e., to engage the front sideof the subject's abdomen, and a back plate 105 at the opposite side ofthe appliance to engage the subject's back. The base member 104 isconnected to the back plate 105 by a pair of flexible belts 101 a, 101b, to thereby define the closed loop 101 enabling the appliance to beworn by the subject. Each of the flexible belts includes a lockingmember or buckle 106, 107 of the type which permits the lenght of thebelt to be adjusted and locked, to thereby enable the appliance to fitdifferent sized persons.

[0053] Base member 104 at the front side of the appliance carries anelectrical motor 111 having an output shaft 112 eccentrically coupled atits opposite ends to a pair of shaped vibrator heads 113, 114 carried byplates 115, 116 pivotally mounted to he base member 104. Each of theeccentric couplings between the motor output shaft 112 and the vibratorheads 113, 114 includes a dashpot device 117, 118 pivotally mounted toplates 115, 116. Each dashpot device 117, 118 includes an adjustment,indicated by screws 117 a, 118 a, which permits manual adjustment of theretarding action of the respective dashpot. The retarding action of eachdashpot may also be remotely adjusted via electrical or hydraulic means.These adjustments may be used not only for adjusting the cushioningforces applied by the vibrator heads 113, 114 against the subject'sabdomen, but also for changing the relative phases of the forces soapplied, upon rotation of the electrical motor 111.

[0054]FIG. 15 illustrates the external appearance of a vibratorappliance 120 constructed in accordance with the present invention. Theappliance includes a backrest 121, a seat 122 and a pair of arms 123,124, each having a rear section 123 a, 124 a, pivotally mounted to thebackrest 121, and a front section 123 b, 124 b, carrying a vibrator head125, 126 to engage the front side of the subject's abdomen. The rear armsections 123 a, 124 a are pivotally mounted to the backrest 121, asschematically indicated by integral hinge 127, and may be fixed in anypivotted position by any suitable means such as a screw and nutarrangement (not shown). Similarly, the front arm sections 123 b, 124 bare pivotally mounted to their respective rear arm sections 123 a, 123b, as indicated by integral hinges 127, and may also be fixed in anypivotted position, to thereby enable the appliance to be used withrespect to persons of different sizes. The vibrator heads 125, 126carried by the front arm sections 123 b, 124 b, may be drivenelectrically, hydraulically, or pneumatically, according to any of theabove-described arrangements.

[0055]FIG. 16 illustrates a dialysis set particularly useful withrespect to the above-described appliance. The illustrated set includestwo supply bags 131, 132 for containing fresh dialysis solution, and adrainage bag 133 to receive the solution after drained from the subject.The three bags are connected to a connector 134 for the dialysiscatheter (not shown) by tubing generally designated 135. Tubing 135includes two tubes 136, 137, connected at one of their ends to therespective supply bag 131, 132, and at their opposite ends to a thirdtube 138 leading to the catheter connector 134. Tube 138 is connected toa fourth tube 139 leading to the drainage bag 133.

[0056] Each tube 136, 137 includes a valve 140, 141 which is normallyclosed, but which can be manipulated to open and thereby to permit therespective supply bag 131, 132 to instill its fluid to the patient viathe catheter connected to connector 134. Valves 140, 141 may bebreakaway valves which are normally closed, but which may be manuallybroken-away to open the valve.

[0057] In use of the dialysis set illustrated in FIG. 16, the two supplybags 131, 132 would be mounted at a higher elevation than the catheterconnector 134, and the drainage bag 133 would be mounted at a lowerelevation than the catheter connector. In addition, an external clamp(not shown) would be applied to tube 139 to prevent the dialysissolution from passing to the drainage bag 133 during instillation phase.With a clamp thus applied to tube 139, valve 140 would be manipulated toopen, thereby permitting the fluid to flow by gravity from supply bag131 via the catheter into the abdominal cavity, whereupon the vibratorappliance would be energized to enhance the rate of solute removal.After the appropriate dwell time, the clamp would be removed from tube139 to permit the solution to drain into the drainage bag 133, whereuponthe clamp would then be reapplied to tube 139 and valve 141 of supplybag 132 would be opened to permit the solution in that bag to flow bygravity into the abdominal cavity of the subject.

[0058] The dialysis set illustrated in FIG. 16 may thus be connected tothe patient's catheter during two successive exchanges, therebysubstantially reducing the possibility of an infection and also reducingthe disruption to the patient's daily routine.

[0059] Generally speaking, it was found that a 40-minute dialysatetreatment accompanied by mechanical vibrations applied in any of theabove-described appliances effects about the same solute transfer as a6-hour dialysate treatment not accompanied by mechanical vibrations.Accordingly, such an appliance permits various treatments to be applied,according to the nature of each case and the convenience of the subject.Following are examples of such treatments:

[0060] (1) Each 24-hour day is divided into two 12-hour periods, eachperiod including a vibration session for 15-60 minutes, and anon-vibration session with fresh dialysate solution for the remainder ofthe period.

[0061] (2) Each 24-hour day includes four vibration sessions of 15-60minutes each, spaced about six hours apart.

[0062] (3) Each 24-hour day is divided into four 6-hour periods, atleast one of these periods including a vibration session for 15-60minutes, and a non-vibration session with fresh dialysate solution forthe remainder of the period, each of the remaining periods being anon-vibration session with fresh dialysate.

[0063] (4) Each 24-hour day includes a vibration session for 15-60minutes, a non-vibration session with fresh dialysate solution for10-11.5 hours, and another vibration session with fresh dialysate for15-60 minutes.

[0064] (5) Each 24-hour day includes six equally-spaced 1-1.5 hourseach, each period including instilling fresh dialysate solution for10-15 minutes, a dwell accompanied by vibrations for 30-60 minutes, andremoving the dialysate solution for 15-20 minutes.

[0065] In all the above treatments except treatment (4) above, eachsession (vibrating or non-vibrating) should involve the instillation of2-2.5 liters of the dialysate fluid. However, in treatment (4) above,since there are a total of only three sessions during the 24-hour day,each session should involve the instillation of about 2.5-3.0 liters ofthe dialysate fluid.

[0066] Each vibration session should be between 15-60 minutes, a 40minute period having been found to be preferred in most cases. Inaddition, after each vibration session the dialysate should be drainedand fresh dialysate added for the next session.

[0067] When the vibrator appliance is used for a continuous 24-hour day(CAPD) treatment, it may be constructed as described above so as to beworn on the user, thereby enabling the user to perform daily routines inthe least-disruptive manner. However, when the vibrator appliance is notto be used continuously, it may be incorporated in a self-supportingstructure, such as a chair as described above, or a stand or table.

[0068] It was further surprisingly found that when the vibratorappliance was operated at the lower frequencies, e.g., 1-3 Hz, itpromoted sleep on the part of the wearer. Actually, during clinicalexperiments, the wearers frequently went to sleep when the appliance wasoperated at these lower frequencies 1-3 Hz, but immediately awoke whenthe vibrations were stopped or the frequency was increased to the 2-6 Hzrange. The illustrated appliance may therefore be advantageously usedalso for promoting sleep.

[0069] While the invention has been described with respect to severalpreferred embodiments, it will be appreciated that these are set forthmerely for purposes of example, and that many variations may be made.For example, in all the described devices, the two vibrators can beoperated at the same frequency but with different phases, at differentfrequencies, or at progressively changing frequencies. In addition,whereas the above described embodiments include two vibrators engagingopposite sides of the subject's abdomen, a different number of vibratorscould be used. Also, the dashpot devices illustrated in FIGS. 13 and 14may be used with any of the other vibrator devices between the vibratorheads and the respective drives. Many other variations, modificationsand applications of the invention will be apparent.

1. An appliance to enhance the rate of removal of solutes during aperitoneal dialysis treatment of a subject, comprising: a holder to beapplied to the subject; and at least one vibrator device carried by saidholder at a location thereof to engage the subject's abdomen and toapply localized inwardly-directed mechanical vibrations thereto at afrequency of 1-15 Hz.
 2. The appliance according to claim 1 , whereinsaid vibrator device applies said mechanical vibrations to the subject'sabdomen at a frequency of 2-6 Hz.
 3. The appliance according to eitherof claims 1 or 2, wherein there are at least two vibrator devicescarried by said holder at locations to engage opposite sides of thesubject's abdomen and oriented to apply inwardly-directed mechanicalvibrations towards the central region of the subject's abdominal cavity.4. The appliance according to any one of claims 1-3, wherein said holderincludes a loop constructed to be worn in a self-supporting manner onthe subject's body.
 5. The appliance according to claim 4 , wherein saidholder further includes a shoulder harness to be worn by the subject toaid in supporting the appliance in a self-supporting manner on thesubject's body.
 6. The appliance according to any one of claims 1-3,wherein said holder includes a backrest engageable with the back of thesubject.
 7. The appliance according to claim 6 , wherein said holderfurther includes a seat for seating the subject.
 8. The applianceaccording to any one of claims 1-7, wherein each of said vibratorydevices includes a rotary motor driving an eccentric arm.
 9. Theappliance according to any one of claims 1-7, wherein each of saidvibratory devices includes a solenoid oscillating an armature.
 10. Theappliance according to any one of claims 1-7, wherein each of saidvibratory devices includes a rotary motor driving an eccentric weight.11. The appliance according to any one of claims 1-7, wherein each ofsaid vibratory devices includes a fluid driven piston reciprocatablewithin a cylinder.
 12. The appliance according to any one of claims 1-7,wherein each of said vibratory devices includes an inflatable bag. 13.The appliance according to any one of claims 1-7, wherein said holdercomprises a first belt dimensioned to enclose the wearer; a second beltdimensioned to enclose said first belt; each of said vibrator devicescomprising at least one rigid plate pivotally mounted at its oppositeends to said first and second belts so as to be pivotal through aplurality of positions from substantially 0° to 180° with respect tosaid belts; and a drive for reciprocating said second belt with respectto said first belt to thereby oscillate said rigid plates through saidplurality of positions.
 14. The appliance according to claim 13 ,wherein each of said vibrator devices comprises a group of said rigidplates pivotally mounted at their opposite ends to said first and secondbelts at spaced intervals therealong.
 15. The appliance according toclaim 14 , wherein said plurality of rigid plates are of decreasinglength from one end of the group to the opposite end of the group. 16.The appliance according to any one of claims 1-7, wherein each of saidvibrator devices includes a shaped vibrator head carried by said holderto be in contact with the subject's abdomen and cyclically movableinwardly and outwardly to apply said mechanical vibrations to thesubject's abdomen.
 17. The appliance according to claim 16 , whereinsaid holder includes a flexible belt and an electrical motor fortensioning and relaxing said belt; said vibrator heads being carried bysaid flexible belt and being movable inwardly and outwardly against thesubject's abdomen by the tensioning and relaxing of said flexible beltby said electrical motor.
 18. The appliance according to claim 16 ,wherein said holder includes a mounting member mounting said vibratorheads, and further mounting an electrical motor coupled to said vibratorheads by coupling devices which, upon energization of the motor,cyclically move said vibrator heads inwardly and outwardly against thesubject's abdomen.
 19. The appliance according to any one of claims 1-7,wherein each of said vibrator devices includes a dashpot which isselectively adjustable to vary the phase of the mechanical vibrationsapplied thereby to the subject's abdomen.
 20. The appliance according toany one of claims 1-19, wherein said vibrator devices operate at thesame frequency and phase.
 21. The appliance according to any one ofclaims 1-19, wherein said vibrator devices operate at the same frequencybut at different phases.
 22. The appliance according to any one ofclaims 1-19, wherein said vibrator devices operate at differentfrequencies to produce alternating in-phase and out-of-phase movementsof the subject's abdomen.
 23. A method of administering a peritonealdialysis treatment to a subject comprising a vibration session,including: instilling a dialysate solution into the peritoneal cavity ofthe subject; applying external localized mechanical vibrations to theabdomen of the subject at a frequency of 1-15 Hz and an amplitude of1-20 mm; and draining said dialysate solution from the subject'sabdominal cavity.
 24. The method according to claim 23 , wherein saidmechanical vibrations are applied at a frequency of 2-6 Hz and atamplitudes of 5-10 mm.
 25. The method according to either of claims 23or 24, wherein said external mechanical vibrations are applied by atleast two vibrator heads to opposite sides of the subject's abdomen onopposite sides of its center line and oriented towards the centralregion of the subject's abdominal cavity.
 26. The method according toany one of claims 23-25, wherein said mechanical vibrations are appliedat the same frequency and phase.
 27. The method according to any one ofclaims 23-25, wherein said mechanical vibrations are applied at the samefrequency but at different phases.
 28. The method according to any oneof claims 23-25, wherein said mechanical vibrations are applied atdifferent frequencies to produce alternating in-phase and out-of-phasemovements of the subject's abdomen.
 29. The method according to any oneof claims 23-28, wherein each 24-hour day is divided into two 12-hourperiods, each period including a said vibration session for 15-60minutes, and a non-vibration session with fresh dialysate solution forthe remainder of the period.
 30. The method according to any one ofclaims 23-28, wherein each 24-hour day includes four vibration sessionsof 15-60 minutes each, spaced about six hours apart.
 31. The methodaccording to any one of claims 23-28, wherein each 24-hour day isdivided into four 6-hour periods, at least one of said periods includinga vibration session for 15-60 minutes, and a non-vibration session withfresh dialysate solution for the remainder of the period, each of theremaining ones of said periods being a non-vibration session with freshdialysate.
 32. The method according to any one of claims 23-28, whereineach 24-hour day includes a said vibration session for 15-60 minutes, anon-vibration session with fresh dialysate solution for 10-11.5 hours,and another said vibration session with fresh dialysate for 15-60minutes.
 33. The method according to any one of claims 23-28, whereineach 24-hour day includes six equally-spaced periods of 1-1.5 hourseach, each period including instilling fresh dialysate solution for10-15 minutes, a dwell accompanied by vibrations for 30-60 minutes, andremoving the dialysate solution for 15-20 minutes.
 34. The methodaccording to any one of claims 23-33, wherein said mechanical vibrationsare applied by vibrator devices carried by a holder worn in aself-supporting manner on the subject's body.
 35. The method accordingto any one of claims 23-33, wherein said mechanical vibrations areapplied by vibrator devices carried by a backrest engageable with theback of the subject.
 36. The method according to claim 35 , wherein saidmechanical vibrations are applied while the subject is seated on a seatcarrying said backrest and said vibrator devices.
 37. A dialysis setparticularly useful with the apparatus of any one of claims 1-22 andmethod of any one of claims 23-36, comprising: two supply bags for aperitoneal dialysis solution to be instilled into a subject's abdominalcavity; a drainage bag for receiving the dialysis solution to be drainedfrom the subject's abdominal cavity; and tubing connecting said twosupply bags and said drainage bag to a catheter to be used for theperitoneal dialysis; said tubing including first and second tubes eachconnected at one of their ends to one of said supply bags and at theiropposite ends to one end of a third tube; said third tube beingconnected at its opposite end to a connector for a catheter, and at anintermediate point to a fourth tube connected to said drainage bag; saidtubing further including a breakaway valve in each of said first andsecond tubes for selectively controlling the flow of fluid from thesupply bags to said catheter.